The precision and accuracy of HPLC and FPIA for the measurement of flecainide plasma levels were compared below, in and above the therapeutic range (200-1,000 ng/ml). Following a calibration crossover study, five standard plasma solutions of varying flecainide concentrations (SPS) and 99 flecainide containing plasma samples of 24 in-patients (IPS) were analyzed with both methods. The results show that within the range of approximately 500-1,500 ng/ml, the two methods did not differ in either precision (expressed as coefficient of variation, CV) or accuracy (expressed as relative error, RE). Close to the lower limit and below the therapeutic range however, HPLC provided greater precision and accuracy than FPIA.